"We have successfully executed an on-time start for this Phase III study. ANDES is designed to confirm the extensive data that we saw in ARISE, our long term Phase III outcomes trial, demonstrating the ability of AGI-1067 to improve diabetic control," said Rob Scott, M.D., Executive Vice President of Research & Development and Chief Medical Officer at AtheroGenics."
"Diabetes has become one of the major health problems facing both physicians and patients today. Statistics show that the majority of the 14 million Americans who are currently diagnosed with diabetes are failing to reach accepted standards of blood sugar control. We desperately need new diabetes therapeutic options that have demonstrated overall cardiovascular safety," remarked Sherwyn Schwartz, M.D., Chief Executive Officer and Chief Medical Officer of DGD Research, and lead U.S. investigator for ANDES. "ANDES is an important study that could verify the potential therapeutic benefit of AGI-1067 in the control of blood sugar levels and perhaps provide us with another tool to treat this complicated disease."
ANDES is a double-blind, placebo controlled study being conducted at sites in the United States, South Africa, Eastern Europe and India. The trial is designed to randomly assign approximately 1,200 patients with confirmed type II diabetes mellitus to one of three doses of AGI-1067 (75, 150, and 300 mg) or placebo for 25 weeks. All patients enrolled in the trial will be on one or no anti-diabetic medication. The key objective of ANDES is to compare the effects three doses of AGI-1067 versus placebo on glycemic endpoints. AtheroGenics is planning to conduct an interim analysis in mid-2008, and the study is expected to conclude before the end of 2008.
About AGI-1067
AGI-1067 has demonstrated efficacy in over 2,200 diabetic subjects showing improvements in glycemic control. This effect with AGI-1067 has been confirmed in other clinical and preclinical studies. Oxidative stress and inflammation have been demonstrated to play a central role in the pathogenesis of insulin resistance and diabetes. AGI-1067 is an anti-inflammatory antioxidant agent that works by inhibiting signaling pathways that are activated in response to oxidative stress and pro-inflammatory stimuli.
AGI-1067 has been evaluated in numerous pre-clinical and clinical studies, including a recent cardiovascular clinical outcomes study comprised of 6,144 subjects followed for up to three years. In that study, AGI-1067 achieved significant results in important pre-specified diabetes endpoints, demonstrating an improvement in glycemic control in patients with diabetes already being managed by conventional therapies. In addition, the number of study subjects who developed diabetes for the first time was reduced by more than 60 percent.
About Type II Diabetes
Type II diabetes is a complicated disease that is characterized by elevated blood sugar levels as a result of resistance to the effects of insulin, and the subsequent failure of pancreatic beta cells, which are responsible for insulin production. It is believed that oxidative stress and inflammation play a major role in both the development of insulin resistance and damage to the pancreas. Oxidation and inflammation are also thought to play a key role in the development and progression of cardiovascular disease in addition to type II diabetes.
Type II diabetes is associated with long-term complications, including damage to the small blood vessels in the eye, kidney and nervous system, called microvascular disease (retinopathy, nephropathy, and neuropathy) and damage to larger blood vessels, called macrovascular disease, leading to myocardial infarction (heart attack), peripheral vascular disease, and stroke. Cardiovascular disease, including heart attack and stroke, ultimately kills two out of three people with diabetes.
About AtheroGenics
AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including diabetes and coronary heart disease (atherosclerosis). AtheroGenics has commenced enrollment in a Phase III clinical trial called ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study) to study its lead drug candidate AGI-1067 as an oral therapy for the treatment of diabetes. In addition, the Company has a development program studying AGI-1096, an oral agent in Phase I that is being developed for the prevention of organ transplant rejection in collaboration with Astellas. For more information about AtheroGenics, please visit http://www.atherogenics.com.
Disclosure Regarding Forward-Looking Statements
Statements contained in this press release that relate to events or developments that we expect or anticipate will occur in the future are deemed to be forward-looking statements, and can be identified by words such as "believes," "intends," "expects" and similar expressions. AtheroGenics cautions investors not to place undue reliance on the forward-looking statements contained in this release. These and other such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. Additional information relating to the safety, efficacy or tolerability of AGI-1067, may be discovered upon further analysis of trial data. The Food and Drug Administration might not allow us to conduct further studies of the efficacy of AGI-1067 for the same or new endpoints, and, to the extent approved, additional clinical trial work may take a significant period of time to complete or require significant additional resources to complete. There may be significant costs incurred by AtheroGenics as a result of AstraZeneca's decision to terminate the AGI-1067 collaboration and license agreement. We cannot ensure that AGI-1067 will ever be approved or be proven safe and effective for use in humans. These and other risks are discussed in AtheroGenics' Securities and Exchange Commission filings, including, but not limited to, the risks discussed in AtheroGenics' Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and are specifically incorporated by reference into this press release. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact:
AtheroGenics, Inc. Mark P. Colonnese Executive Vice President 678-336-2511 Email Contact
Media Inquiries Jayme Maniatis Schwartz Communications, Inc. 781-684-0770 Email Contact
Investor Inquiries Lilian Stern Stern Investor Relations, Inc. 212-362-1200 Email Contact
Source: AtheroGenics
